This study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.

An Open Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneously Administered Efalizumab Used in Combination With Topical Psoriasis Therapies for Prolonged Maintenance Treatment

A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening

Plaque psoriasis covering >=10% of total Body Surface Area (BSA)

In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept)

18 to 70 years old

Exclusion Criteria:

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis

Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug

Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol

Topical therapy for psoriasis

Systemic therapy for psoriasis

Systemic immunosuppressive drugs

Tanning beds, booths, or home UV light sources

Live virus or bacteria vaccine

Other vaccines or allergy desensitization injections

Other experimental drugs or treatments

Nonsteroidal anti inflammatory drugs

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.